Clinical Study of Approved Contact Lenses

NCT03351101 | Completed Results FDA Device

• 1 other identifier: ROC2-17-014
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 11

Brief Summary

Evaluation of Johnson \& Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• End of Day Comfort

  The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.

  1 month

• Overall Vision

  The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.

  1 month

Study Arms (2)

Senofilcon C

EXPERIMENTAL

Senofilcon C Contact Lens

Device: Senofilcon C

Samfilcon A

EXPERIMENTAL

Samfilcon A Contact Lens

Device: Samfilcon A

Interventions

Senofilcon C DEVICE

Senofilcon C Contact Lens

Senofilcon C

Samfilcon A DEVICE

Samfilcon A Contact Lens

Samfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent.
• Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
• Subjects must be willing and able to comply with all treatment and follow-up/study procedures.
• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes).
• Subjects must be habitual wearers of Johnson \& Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye.
• Subjects must use a contact lens care regimen on a routine basis.
• Subjects must agree to wear their study lenses on a daily wear basis for the duration

You may not qualify if:

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation
• Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
• she is currently pregnant
• she plans to become pregnant during the study
• she is breastfeeding
• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (11)

valeant Site 02

San Diego, California, 92123, United States

Location

Valeant Site 03

San Francisco, California, 94112, United States

Location

Valeant Site 04

Denver, Colorado, 80246, United States

Location

Valeant Site 06

Orlando, Florida, 32803, United States

Location

Valeant Site 01

Orlando, Florida, 32812, United States

Location

Valeant Site 05

Sarasota, Florida, 34232, United States

Location

Valeant Site 07

Pittsburg, Kansas, 66762, United States

Location

Valeant Site 08

Warrensburg, Missouri, 64093, United States

Location

Valeant Site 09

Vestal, New York, 13850, United States

Location

Valeant Site 10

Powell, Ohio, 43065, United States

Location

Valeant Site 11

New Berlin, Wisconsin, 53151, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

Robert.Steffen@bausch.com

+1 (585) 338-6399

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 22, 2017
• Study Start: October 23, 2017
• Primary Completion: November 10, 2017
• Study Completion: December 8, 2017
• Last Updated: January 8, 2021
• Results First Posted: September 16, 2020

Record last verified: 2021-01

Locations

US (11)